Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahey Clinic
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• Female patients > 18 years of age

• OAB symptoms for > 3 months

• Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.

• May or may not be accompanied by urinary frequency

• May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria:

• Male Patients

• Underlying cortical or spinal cord pathology including SCI, MS, or

• Parkinson's Disease

• Urinary retention with post-void residual > 150cc

• Current treatment or treatment within the last 3 months with anticholinergic medications

• Patients not able to complete the questionaires or voiding diaries in English

• Pregnancy

• Active urinary tract infections

• Bladder Cancer or unevaluated hematuria

• Known diagnosis of narrow angle glaucoma

• Severe constipation

• History of reduced renal function (CrCl<30ml/min)

• History of liver disease

• Current treatment with cytochrome P450 inhibitor medications